A phase I/II trial of isotoxic accelerated radiotherapy in the treatment of patients with non-small cell lung cancer

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN74841904

Enrollment

121

Registered

2011-06-10

Start date

2012-03-12

Completion date

Unknown

Last updated

2019-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: National Cancer Research Network

Interventions

Phase I will have two groups, each with 6 to 12 particpantss who will be treated at each of up to 4 dose levels until the MTD recommended Phase II dose is identified. 49 patients need

Follow Up Length: 24 month(s)

Study Entry : Registration only

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically or cytologically confirmed stage II ? IIIb NSCLC (Appendix II) 2. Inoperable disease (as assessed by a lung cancer MDT with thoracic surgical input) or operable but the patient refuses surgery 3. Disease which can be encompassed within a radical radiotherapy treatment plan in keeping with standard practice at the participating centre 4. World Health Organisation (WHO) Performance Status 0 or 1 (Appendix III) 5. Adequate respiratory function: Forced expiratory volume in the first second (FEV1) = 1.0 litre, diffusing capacity of the lung for carbon monoxide (DLCO) (transfer factor) = 40% of predicted and carbon monoxide transfer coefficient (Kco) (Dlco/VA) > 40% predicted on baseline lung function tests 6. Blood haemoglobin should be = 10g/dL 7. No prior thoracic radiotherapy 8. Age more than or equal to 16 years 9. Considered fit to receive trial treatment 10. Estimated life expectancy of more than 3 months 11. Written informed consent obtained 12. Patient consents for electronic CT scan and planning data to be used for future research 13. Patient is available for follow up; Target Gender: Male & Female ; Lower Age Limit 16 years

Exclusion criteria

Exclusion criteria: 1. Medically unstable (e.g. unstable diabetes, uncontrolled hypertension, infection, hypercalcaemia or very symptomatic ischaemic heart disease) 2. Previous or current malignant disease likely to interfere with protocol treatment 3. Pancoast tumours 4. Connective tissue disorders (e.scleroderma, systemic lupus erythematosus) 5. Interstitial lung disease 6. Women who are pregnant or lactating 7. Women of childbearing potential who are not using adequate contraceptive precautions

Design outcomes

Primary

Measure	Time frame
Grade 3 or 4 toxicities; Timepoint(s): occuring up to three months after radiotherapy	—

Secondary

Measure	Time frame
1. Dose Limiting Toxicity; Timepoint(s): occuring up to six months after radiotherapy (RT) 2. Estabilsh Maximum Tolerated Dose to the oesophagus; Timepoint(s): acute grade 3 or 4 toxicity occuring up to two months after radiotherapy 3. Local control; Timepoint(s): to the date of first clinical evidence of progressive disease at the primary site, or death 4. Overall Survival; Timepoint(s): date of entry to date of death 5. Tumour response; Timepoint(s): assessed using Response Evaluation Criteria In Solid Tumors (RECIST) at 2 months post RT	—

Measure

Time frame

1. Dose Limiting Toxicity; Timepoint(s): occuring up to six months after radiotherapy (RT) 2. Estabilsh Maximum Tolerated Dose to the oesophagus; Timepoint(s): acute grade 3 or 4 toxicity occuring up to two months after radiotherapy 3. Local control; Timepoint(s): to the date of first clinical evidence of progressive disease at the primary site, or death 4. Overall Survival; Timepoint(s): date of entry to date of death 5. Tumour response; Timepoint(s): assessed using Response Evaluation Criteria In Solid Tumors (RECIST) at 2 months post RT

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 24, 2026